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EU GMP focus will shift from post- to pre-approval review under MRA, Glaxo's Hitchings predicts.

Executive Summary

EU INSPECTION FOCUS WILL SHIFT TO PRE-APPROVAL GMPs UNDER MRA, GLAXO predicted June 24 at the Drug Information Association annual meeting in Montreal. As a result of the Good Manufacturing Practices Mutual Recognition Agreement signed by the U.S. and the European Union June 20, "what we would anticipate is the European focus changing a bit from post-approval GMP to pre-approval," Glaxo Wellcome (U.K.) Director-Group Quality William Hitchings said. "We're looking to see greater consistency between the inspecting agencies on that standpoint."
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PS030460

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